Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol.

Abstract

Background: Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 hours after onset. Current guidelines recommend administering antiplatelet medications 24 hours after IVT. However, vascular re-occlusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular re-occlusion, prevent microvascular thrombosis, and enhance cerebral blood flow.

Objective: This trial aims to assess whether early administration of tirofiban can improve clinical outcomes in patients with AIS who received IVT.

Methods and design: The Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis (ASSET IT) Trial is an investigator-initiated, randomized, placebo-controlled, double-blind, multi-center study. Up to 832 eligible patients will be consecutively randomized in a 1:1 ratio to receive either intravenous tirofiban or placebo over a period of 2 years across 38 stroke centers in China.

Outcomes: The primary endpoint is excellent functional status at day 90, defined as a modified Rankin Score of 0-1. Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 hours and mortality at 90 days.